Summary

Eligibility
for people ages 65 years and up (full criteria)
Location
at Los Angeles, California
Dates
study started
completion around
Principal Investigator
by Zhuang Fang, MD

Description

Summary

The goal of this study is to assess any post operative cognitive changes following benzodiazepine administration during cataract surgery. The investigators will compare effects of Midazolam vs. Remimazolam on cognition at the time of discharge from the post operative care unit and the next day following surgery.

Cognitive changes will be assessed by administration of Montreal Cognitive Assessment (MoCA).

Participants will:

  1. Complete MoCA testing prior to surgery
  2. Randomize in either Midazolam or study drug Remimazolam
  3. Complete MoCA testing after surgery at the time of discharge in the post anesthesia care unit and the next day of surgery at the time of post operative surgical visit.
  4. Complete Patient Satisfaction Survey at the time of discharge from the Post Anesthesia Care Unit (PACU)

Official Title

Comparison of Remimazolam vs. Midazolam for Sedation During Cataract Surgery

Details

Cataract surgery (clouded natural lens of eye removed and clear artificial lens implanted) is the most common eye surgery performed in elderly patients. Although cataract surgery is a minor surgery, many patients are anxious and therefore benzodiazepine such as midazolam is administered during surgery to allay a patient's anxiety.

The purpose of this study is to look at any difference in postoperative cognitive changes as well as recovery times in the PACU following administration of midazolam or remimazolam.

Patients will be asked to participate in a clinical trial where they will be randomly assigned to midazolam or remimazolam group. Cognitive changes will be assessed by administration of MoCA test. MoCA test is a validated, objective short (about 10-15 minutes) screening tool for detection of mild neurocognitive dysfunction. Given the short half life of remimazolam, investigators hypothesize that any cognitive changes will be less with remimazolam compared to midazolam.

Patients will be asked to complete MoCA prior to surgery, in the recovery room following surgery, and the next day during their post-operative clinic visit. In addition, patients will be asked to rate their satisfaction of their anesthetic during their surgery.

The participant will be in this research study from the day of surgery until the first post-operative visit, the following day.

Keywords

Cataract Surgery, Cognitive Impairment, Midazolam, Remimazolam, Outcomes, Cataract

Eligibility

You can join if…

Open to people ages 65 years and up

  1. Adult patients age > 65 years undergoing first eye cataract surgery under local topical anesthesia at the University of California, Los Angeles (UCLA).
  2. Both male and female patients
  3. American Society of Anesthesiologists Class 2, 3, and 4.

You CAN'T join if...

  1. Patients who are unable to consent for the study
  2. Patients who are unable to cooperate with the cognitive assessment such as patients with significant visual, auditory, language or other impairment.
  3. Patients who are unable to understand simple English commands.
  4. Patients who do not wish to have benzodiazepine medication during surgery
  5. Patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40.
  6. Patients with chronic pain on opiates.
  7. Patients with a history of drug, alcohol abuse/dependence.
  8. Patients with BMI > 40.
  9. Patients with obstructive sleep apnea (moderate to severe).

Location

  • Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine
    Los Angeles California 90095 United States

Lead Scientist at UCLA

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT05980117
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated